Patient Safety Scientist/Sr. Scientist (Data & Systems)
AstraZeneca Pharmaceuticals - Wilmington, DE
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- Company
- AstraZeneca Pharmaceu... AstraZeneca Pharmaceuticals
- Location
Wilmington, DE, US
- Job Type
- Regular
- Job Classification
- not provided
- Experience
- not provided
- Education
- not provided
- Company Ref #
- 040000581968040000581968
- AJE Ref #
- 555397920
- [+] More
Job Description
Job Advertised by Pharmadiversity Job Board - Scientist/Sr. Scientist PS Data & Systems PLEASE NOTE: This position is in the Patient Safety group, however, Patient Safety experience is not required. Data and Systems (IS/IT) experience is required for this role. Description Lead scientific, technical or patient safety input for systems or processes across the Patient Safety Regions Accountabilities/Responsibilities * Lead the scientific and technical contributions for one or more of the Support Section activities within the Region * Lead or contribute to the development and implementation of new safety-related systems, processes and procedures across Regions * Represent the Region on specific Patient Safety Process Teams * Take ownership for a local or global process with empowerment to represent the region * Support a performance-driven culture * Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures * Maintain knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development * Provide support for US local processes * Demonstrate working knowledge of FDA regulations relevant to Patient Safety * Serve as a US Patient Safety representative on local and global teams * Contributes to the development of local quality control processes * Review safety data output (PSURs etc.) for accuracy and completeness prior to submission to internal and external sources * Serve as a knowledge resource on adverse event reporting internal to Patient Safety staff as well as to AZ personnel in areas outside of Patient Safety * Support regulatory inspections and internal audits * Support Clinical, US Business and Marketing Companies The Patient Safety Senior Systems Scientist, Wilmington will, in addition: * Develop standard and ad hoc data extracts and reports for internal and external use * Review safety data output for accuracy and completeness prior to submission to internal and external sources * Provide guidance to Patient Safety on data consistency and medical terminology issues that relate to safety systems * Represent Patient Safety in areas of system, data and reporting standards * Analyze pharmaceutical data and supply accurate aggregate clinical data in a timely manner * Provide data mining and Quantitative Signal Detection guidance to Patient Safety Surveillance for custom, standard and ad-hoc reporting and analysis * Provide extensive end-user support for a wide range of standard desktop applications used by Patient Safety * Provide advanced data visualization and graphing support for all types of Patient Safety data * Conduct application training in both classroom setting and individualized setting * Lead expert working groups in support of systems and applications in use by Patient Safety * Demonstrate expert scientific programming skill set * Develop and execute user testing as required by company SOPs * Provide input to IS/IT teams in the.... br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=581968&tag=aje
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